Prescription drug · NDA
Isosorbide Dinitrate NDC 68682-193
Isosorbide dinitrate 5 mg/1 · Tablet · Oral · Oceanside Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68682-193-01 | 68682019301 | 100 TABLET in 1 BOTTLE (68682-193-01)Marketed from Mar 2, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Isosorbide Dinitrate
- Generic name (nonproprietary)
- isosorbide dinitrate
- Active ingredients
- Isosorbide dinitrate — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oceanside Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012093
- Marketing start
- Listing expires
- Other FDA classes
- Nitrates (Chemical structure)Vasodilation (Physiologic effect)
- Identifiers
- Product ID 68682-193_723d9f78-9d77-4575-af27-1aa117e6b8d7SPL ID 723d9f78-9d77-4575-af27-1aa117e6b8d7SPL set ID 723d9f78-9d77-4575-af27-1aa117e6b8d7RxCUI 197840, 314055UNII IA7306519NUPC 0368682193015
- Pharmacologic class
- Nitrate Vasodilator
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468682019301followed by a unit qualifier and the quantityPackage 68682-0193-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Isosorbide Dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode.
Excerpt only. Read the full label for complete information.